1. Field of the Invention
The present invention relates to a disposable bandage designed to quickly detect and alert medical personnel of external bleeding in post angioplasty patients. More specifically, the present invention relates to a bandage within which is provided an open D.C. circuit capable of being closed by the patient's blood in order to activate an alarm.
2. Description of the Related Art
A variety of medical procedures involve puncturing of a large artery. Some of these procedures are Cardiac Catheterization (also known as Left Heart Catheterization, LHC, Coronary Angiography, or Coronary Arteriogram), Percutaneous Transluminal Angioplasty (also known as PTA), Percutaneous Transluminal Coronary Angioplasty (also known as PTCA), Percutaneous Coronary Atherectomy, Directional Atherectomy, Percutaneous Transluminal Coronary Rotoblator, Stents (including Renal, Biliary and Intracoronary Stents), and Electrophysiology Studies.
Typically the artery involved is either the Right or Left Femoral Artery. When the Femoral Arteries are not available, usually due to blockage, either the Left or Right Brachial Artery is normally used.
Generally, these procedures are done in order to increase blood flow in the body where the flow has become restricted due to the gradual buildup of plaque in the arteries.
The procedure is started by identifying the artery to be used. Then the site is shaved, cleaned, and an anesthetic agent is used to numb the area. A small scalpel blade is then used to make an incision through the skin. This allows access through the "tougher" layers of the skin. Then a large "needle" with a plastic sheath or tube (much like a large Intravenous Catheter) approximately six inches long (Atherectomy sheaths can be as long as 18 inches) is advanced into the chosen artery. When this is accomplished, the "needle" is removed from the sheath. This gives the doctor easy access from outside the body to the interior of the artery. Again, this is much like the process used when placing an IV catheter except for the much larger size of the "needle" and sheath. The sheath is also known as an Introducer, because the doctor is allowed to "introduce" wires into the artery via the sheath. The sheath is provided with a plug which prevents blood from flowing outside the patient's body, but through which specially designed wires can be inserted into and removed from the artery.
Once this is accomplished, the doctor is then able to thread a catheterization wire through the sheath, into the artery and into the coronary arteries. This wire is extremely small, typically a couple of millimeters in diameter. With this device, the doctor is able to inject a radiopaque dye into the coronary arteries. He may also inject dye into other arteries, if he chooses, by merely manipulating the wire to other parts of the body, for example, the renal arteries, biliary arteries, the aorta, the femoral arteries, or the carotid arteries.
If blockage of an artery is detected, the doctor may opt to intervene using one of the various methods available. All these methods are accomplished via special wires like the cardiac catheterization wires. Each special wire has unique fittings that accomplish the same goal, which is increasing blood flow, but each accomplishes this goal in a slightly different manner. The details of these different methods will not be reviewed herein since they are commonly known in the medical profession. Anticoagulants are administered to the patient when certain of these methods are employed in order to prevent undesirable blood clotting within the arteries.
Once the procedure is completed, the wire with its particular application end is removed from the body via the sheath. This leaves the patient with only a sheath in the artery again, at the puncture site. For patients that did not receive anticoagulants, the sheath is generally removed immediately after the procedure, pressure is held and then the patient recovers after a specified number of hours of bed rest. If the patient received anticoagulants after any procedure, the effect of the anticoagulant must be allowed to lessen before the sheath/introducer is removed, pressure is applied and the patient is then required to remain on bed rest for a specified number of hours while he recovers.
Nursing care during this period of bed rest involves visual and tactile assessment of the puncture site. These assessments occur quite frequently at first, generally about every 15 minutes, and occur less frequently during the course of the patient's care, ending with assessments occurring as infrequently as two hours apart.
In addition to the visual and tactile assessments, most patients are also monitored continuously during this period of time with an electrocardiograph (ECG), either at the bedside or via a remote system. However, if the patient were to begin hemorrhaging from the puncture site, substantial loss of blood generally occurs before the ECG registers any significant and noticeable changes which would alert the nursing staff of a problem. If the patient is asleep when his puncture site begins to bleed, and therefore, unable to call the nursing staff for help, substantial loss of blood can occur before the bleeding is detected.
Currently, there is no means, other than depending on the patient to call the nurses when he begins to bleed, for detecting this type of bleeding early enough to prevent the patient from losing a large volume of blood.
The present invention addresses this need by providing a disposable bandage which is applied over the puncture site and which is equipped with electrical means for detecting bleeding and activating an alarm when bleeding is detected. The present invention is provided with a clear observation window which allows visual and tactile assessment of the puncture site without removing the invention from the patient. The invention is also provided with a flexible segment which connects that portion of the invention which covers the puncture site and another portion of the invention which holds the power source and alarm mechanism. This flexible segment allows the two connected portions to be positioned on the patient's skin in order to allow the patient to be mobile without dislodging or disconnecting the invention.